IVGEL Hand Sanitizer by VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. IVGEL Hand Sanitizer

Drug Details [pdf]

IVGEL HAND SANITIZER- alcohol gel
VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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IVGEL Hand Sanitizer

Drug Fact

Active Ingredients:

Ethyl Alcohol at 70%

Purpose:

Antiseptic

Uses:

Hand Sanitizer to help reduce germs. For use when soap and water not available.

Warning:

For external use only, Flammable. Keep away from open flame and sources of heat or flame.

Do not use:

In children less than 2 months of age. On open skin wounds.

When using this product:

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor:

If irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information:

Store below 110oF (43oC). Avoid freezing. May discolor certain fabrics or surfaces

Inactive Ingredients:

Water, Glycerine, Carbopol, Triethanolamine.

Package Labeling

Label

IVGEL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74967-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 74967-003-00	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020	04/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/27/2020	04/30/2022

Labeler - VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. (589993745)

Revised: 11/2021

Document Id: d12891b9-e4e6-aa6c-e053-2995a90a1dc4

Set id: a79776b8-28e6-af1e-e053-2a95a90a185e

Version: 3

Effective Time: 20211119

VAGO I